Kornimate/medical-research-clean huggingface dataset:
prostate cancer prevention trial with quercetin and genistein

Conditions: Primary Prevention of Prostate Cancer

Summary: the aim of the randomized controlled double-blind crossover trial is to evaluate the effectiveness of two dietary supplements containing polyphenolic phytochemicals (isoflavonoid genistein and flavonoid quercetin) in comparison with placebo on the rate of increase in prostate-specific antigen (psa). in addition, secondary objective is to evaluate the incidence of prostate cancer and to analyze malondialdehyde and protein carbonyle as indicators of the oxidative status.

prostate cancer (pc) is the most frequently occurring cancer in men. its clinical incidence and mortality rates vary geographically, being much lower in asia than in western countries. notably, latent pcs seem to be equally distributed, thus supporting the hypothesis, that environmental factors may be important in prostate cancer progression. moreover, epidemiological evidence strongly supports the concept that the incidence of clinical prostate cancer depends on lifestyle factors, mainly related to diet. the isoflavone genistein and the flavonoid quercetin have been identified as likely preventive candidates. the aim of the intended clinical trial is to evaluate the hypothesized effectiveness of polyphenolic phytochemicals with highly purified dietary supplements in patients at high risk of clinical pc and without systemic treatment. this will provide data, which serve as an important pre-requesite for targeted dietary interventions using alternative medicine as preventive measures in men with latent pc.

Eligibility criteria:
inclusion criteria: * patients with deviant psa constellation: 1. patients with psa 2,5 - 4 μg/l and free psa/total psa \< 15 % 2. patients with psa \> 4 μg/l with negative punch biopsy of the prostate exclusion criteria: * chronic liver diseases, impaired kidney function * inflammatory diseases of the urogenital tract * history of malignancy of any organ system, treated or untreated, within the past three years whether or not there is evidence of local recurrence or metastases * therapy with doxazosin, dutaserid and/ or finasterid, testosteron and other hormonal active medicaments * inflammatory bowel diseases * malabsorption/-digestion * hypersensitivity/allergy to soy * phytotherapy or intake of dietary supplements * smoker * abnormal clinical laboratory values at baseline * participation in any other trial with an investigational new drug * inability to sign informed consent

Keywords: prostate cancer dietary supplements quercetin genistein prostate-specific antigen oxidative status
peer mentorship to reduce suicide risk following psychiatric hospitalization

Conditions: Suicidal Ideation

Summary: every year in the united states about 1 million people make a suicide attempt and more than 38,000 die by suicide. the risk of suicide is highest among individuals with mental illness who have been hospitalized due to suicidal thoughts or behaviors, yet there are few interventions known to reduce suicide risk in this population. this study will develop and pilot test a peer mentorship intervention by which trained peer professionals will use their own personal experience with recovery from mental illness to instill hope and belongingness in high-risk patients and provide additional support to prevent future suicidal thoughts or behaviors. the specific aims of the study are to: (1) develop a peer mentorship intervention to reduce suicide risk among patients psychiatrically hospitalized with suicidal ideation or following a suicide attempt; (2) conduct a randomized controlled pilot study to assess the acceptability, feasibility, and fidelity of the peer mentorship intervention in preparation for a larger efficacy trial; and (3) an exploratory aim will be to measure potential mediators and moderators of intervention effectiveness in terms of belongingness, burdensomeness, and hopelessness according to the interpersonal theory of suicide.


Eligibility criteria:
inclusion criteria: 1. are age 18 years or older 2. have medical record documentation of suicidal ideation or suicide attempt at the time of admission 3. are fluent in english exclusion criteria: 1. substantially cognitively impaired (according to mini-cog) 2. unable to provide voluntary, written, informed consent for any reason (including incompetency) 3. determined by the patient's attending psychiatrist that due to the patient's psychiatric condition peer mentorship may be harmful to the patient or peer specialist (e.g., severe personality disorder, unstable paranoia) 4. already receiving or intending to receive peer mentorship (including having a sponsor from alcoholics anonymous) or participate in group-based peer support on a biweekly or more frequent basis 5. are receiving electroconvulsive therapy (ect) 6. are located more than 50 miles from any of the peer specialists 7. are being discharged to a residential treatment facility

Keywords: peer mentorship psychiatric hospitalization suicide risk
18f-psma pet/mri for the diagnosis of clinically significant prostate cancer

Conditions: Prostate Cancer

Summary: this project aims to evaluate the role of fully hybrid pet/mri with 18f-psma and multiparametric mr imaging (mpmri) as one-stop approach for the diagnosis of clinically significant prostate cancer (cspca). this prospective pet/mri clinical evaluation will ideally reduce the number of false negative findings, while at the same time, allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk, clinically indolent pca. the demonstration that, compared to mpmri alone, the use of pet/mri with 18f-psma has a superior diagnostic accuracy in detecting men with cspca will strongly support the inclusion of 18f-psma as pre-biopsy triage test, in addition to mpmri in daily clinical practice.


Eligibility criteria:
inclusion criteria: 1. men at least 18 years of age referred with clinical suspicion of prostate cancer candidate for prostate biopsy 2. feasibility to undergo all procedures listed in protocol 3. ability to provide written informed consent exclusion criteria: 1. prior diagnosis of prostate cancer 2. contraindication to mri (e.g. claustrophobia, pacemaker, estimated gfr lower or equal to 50mls/min) 3. contraindication to prostate biopsy
prevalence of synovitis in patients with haemophilia a

Conditions: Haemophilia A; Synovitis; Hemophilia Arthropathy; Sonography

Summary: the aim of this study is to evaluate the prevalence of synovitis in adult patients with haemophilia a.

the bleeding disorder haemophilia causes recurrent spontaneous bleedings primarily into the joints and soft tissues. the reason is a congenital lack of factor viii (haemophilia a) or factor ix (haemophilia b). in germany, the most affected joints are the ankle, knee, and elbow. the joint bleedings are accompanied by pain and an inflammatory process that leads to synovitis and ultimately to degenerative joint changes resulting in haemophilic arthropathy: the synovial tissue is responsible for removing blood residuals from the joint cavity. however, blood components, especially iron, induce several changes in the synovial tissue. the resulting synovitis leads to damage of cartilage, bone cysts, osteophytes, and joint effusions. synovitis can even become a bleeding-independent process, especially after repeated bleeding. according to current knowledge, there is no option to prevent synovitis except for preventing bleedings. in the aftermath of recurrent joint bleedings, various changes in the synovial tissue, the articular cartilage, and the subchondral bone and blood vessels are observed. these changes are accompanied by restricted joint mobility and musculoskeletal dysfunction. in addition to these peripheral structural changes, various studies show that the entire musculoskeletal system is also affected by recurrent joint bleedings, as it adapts to pain. improved therapy over the past decades has led to a reduction in major joint bleeding rates. for this reason, it is important to examine whether this has improved the average joint status and how often patients with haemophilia (pwh) are affected by synovitis at all. sonography is the radiation-free method of choice for the initial determination of synovitis. in addition to the structural consequences, joint bleedings also lead to pain and reduction in physical performance. when considering the overall process of degenerative joint changes of pwh, it becomes apparent that this also reduces daily mobility and muscle strength. to the best of our knowledge, the effects of the degree of synovitis on pain perception and physical performance have not been evaluated in previous studies. for this reason, the prevalence of synovitis in pwh and the consequences in relation to the pain situation and physical performance will be investigated.

Eligibility criteria:
inclusion criteria: * participants (≥ 18 years old) suffering from moderate or severe haemophilia a, also with inhibitor or joint replacement * complete documentation of hemophilia severity, treatment history (past 12 months), and bleeding events (past 12 months), inhibitor status (at time of enrollment and in past medical history) * submitted written consent to participate in the study exclusion criteria: * patients suffering from other bleeding disorders conflicting with the research question * patients in clinical studies with investigational drugs

Keywords: synovitis haemophilia a prevalence
creatine supplementation for improved voice performance in the elderly

Conditions: Presbyphonia

Summary: the primary objective of this study is to determine if creatine supplementation improves acoustic, auditory perceptual, physiologic, and patient-reported outcome measures in patients over 65 years of age. in the study, 20 participants will be enrolled and randomly assigned to receive either creatine or placebo.

this will be a double-blinded, placebo-controlled interventional trial. participants will be 65 years or older who present to the nyu voice center for voice complaints and desired voice therapy for improved vocal performance. upon enrollment, participants will undergo evaluation for measures of vocal function (acoustic and aerodynamic measures of voice production), laryngeal physiology (electroglottography, videostroboscopy), and voice-associated quality of life (voice handicap index 10 , omni vocal effort scale, aging voice index). participants will be randomized to receive either daily oral creatine supplementation or placebo. after 4 weeks, repeat measures will be taken. at this time, participants will initiate a standard-of-care course of voice therapy directed at improved vocal strength and endurance. the duration of therapy will be approximately 6 weeks. participants will continue creatine supplementation or placebo through the course of therapy and repeat measures will be assessed at the conclusion of voice therapy. this will mark the end of the study period for each subject.

Eligibility criteria:
inclusion criteria: 1. age 65 years or older 2. desiring to participate in voice therapy exclusion criteria: 1. lesions or abnormalities of the larynx not attributable to normal aging 2. pre-existing renal disease 3. pre-existing liver disease 4. congestive heart failure 5. blood urea nitrogen (bun), creatine, alanine transaminase (alt), aspartate aminotransferase (ast), alkaline phosphatase (alp), gamma-glutamyl transpeptidase (ggt) over reference range in the last 6 months 6. concurrent medication associated with reduced renal clearance (e.g. nonsteroidal anti-inflammatory drugs (nsaids), metformin) 7. history of prior vocal fold augmentation procedures 8. cognitive disability 9. unwillingness to participate in voice therapy

Keywords: creatine presbyphonia presbylarynx vocal atrophy
a trial to determine the long-term durability of virologic suppression in kaletra recipients with imperfect adherence

Conditions: HIV Infection

Summary: this study will enroll completers of a prior 24 week mems cap study of kaletra adherence, conducted in 2005 - 2006, and repeat the mems monitoring for an additional 24 weeks in 2008/2009 on the current antiretroviral anchor drug. the goals of the study are to correlate long-term adherence with virologic outcome, and to explore the stability of mems cap adherence measurements over time.


Eligibility criteria:
inclusion criteria: * participation in the prior kaletra mems cap study exclusion criteria: * not receiving antiretroviral therapy, refusal to provide informed consent

Keywords: hiv adherence mems
timing of target enteral feeding in the mechanically ventilated patient

Conditions: Acute Respiratory Failure

Summary: this study tests the hypothesis that initial trophic enteral feedings will increase the time alive and free of mechanical ventilation as compared to initial goal enteral feedings in patients who are mechanically ventilated.

mechanically ventilated patients, within 48 hours of initiating mechanical ventilation, are randomized in a 1:1 fashion to receive trophic enteral feedings for 96 hours followed by advancement to goal feeding rates or initial advancement to goal feeding rates. primary endpoints are ventilator free days, icu-free days, gastrointestinal intolerances, development of nosocomial infections, and mortality.

Eligibility criteria:
inclusion criteria: patients will be eligible for inclusion in the study if they meet the following criteria: * mechanical ventilation expected to last at least 72 hours. * presence of, or primary physician's intent to place, an enteral feeding tube and begin enteral feeds. exclusion criteria: * more than 48 hours elapsed since both inclusion criteria met. * patient, legal representative, or physician refuses consent or is unavailable to provide consent. * patient, legal representative, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest). * presence of malignant or irreversible condition and estimated 28 day mortality greater than 50%. * severe or refractory shock. * moribund patients not expected to survive 24 hours from start of enteral feeding (as determined by primary medical team). * child-pugh score greater than 10. * presence of partial or complete mechanical bowel obstruction, or ischemia, or infarction. * current tpn use or intent to use tpn within 7 days. * severe malnutrition with bmi less than 18.5 and/or loss of more than 30% total body weight in the previous 6 months. * neuromuscular disease impairing the ability to ventilate spontaneously. * laparotomy expected within 7 days. * unable to raise head of bed 45°. * greater than 30% total body surface area burns. * absence of gi tract/short bowel syndrome - defined as entire length of small bowel totaling 4 feet or less. * presence of high-output (\> 500 cc/day) enterocutaneous fistula. * age less than 13 years * allergy to enteral formula

Keywords: mechanical ventilation acute respiratory failure early nutrition
deep electrical neuromodulation in obsessive-compulsive disorder

Conditions: Obsessive-compulsive Disorder (OCD)

Summary: obsessive-compulsive disorder (ocd) is a neuropsychiatric disease characterised by intrusive, recurrent and persistent thoughts, urges or images (obsessions) and the resulting excessive repetitive behaviours or mental acts according to rigid rules unrealistically aimed at reducing distress (compulsions). its lifetime prevalence in the general population is usually estimated between 1 - 3% (ruscio, mol psychiatry, 2010). despite appropriate pharmacological and cognitive-behavioural treatments, it is commonly estimated that 10% of patients are therapy-refractory and that among improved or recovered patients, sustained efficacy is uncertain. for treatment refractory ocd patients, a neurosurgical treatment by deep brain stimulation (dbs), has emerged in the late 1990s as a new therapeutic option (nuttin et al, lancet, 1999). the objective of the current study is to report the long-term treatment effects (safety and effectiveness) of dbs from the cohort of six severe and therapy-refractory ocd patients implanted at the french university hospital of montpellier since 2003.

the data needed to carry out the study will be extracted from the medical files of the 6 patients concerned. the following data will be collected: * age, sex * medical, surgical and psychiatric history * history of pharmacological treatments * elements from clinical examination * any reported adverse effect * scores of the various questionnaires completed throughout the follow-up (including y-bocs and gaf) * results of biological, morphological, neuropsychological tests * stimulation parameters applied since implantation.

Eligibility criteria:
inclusion criteria: * all patients with severe and refractory ocd according to dsm-iv criteria, confirmed by experienced psychiatrist * treated by dbs at the chu of montpellier exclusion criteria: - already enrolled in a study protocol at time of implantation

Keywords: deep brain stimulation obsessive-compulsive disorder neuromodulation psychiatry quality of life
effectiveness of a warm-up with foam roller in professional basketball players

Conditions: Athletics Injury; Sports Physical Therapy

Summary: the purpose of this study is to analyze the effectiveness of a foam roller warm-up on sports performance in professional basketball players.

twenty-two professional basketball players, divided into two randomized groups, carried out a specific warm-up for three months with a foam roller. three measurements were made, pre-intervention, post-intervention at 12 weeks and a four-week follow-up. in these measurements reference data were taken for jumping, ankle dorsiflexion and balance. during this protocol, they performed three series of sixty seconds of application with thirty seconds of rest between series, three days a week and applied to the calf muscles, hamstrings, quadriceps, gluteus and tfl.

Eligibility criteria:
inclusion criteria: * masculine or feminine * minimum 18 years and maximum 30 * professional players * practice 3 training sessions per week + competition on weekends exclusion criteria: * musculoskeletal injury in the last 3 months * surgery in the lower extremity in the last year * present a diagnosed orthopedic or neurological pathology of the lower limb.

Keywords: foam roller performance warm-up basketball
ct scan guide percutaneous biopsy of lytic bone metastases of lung cancer : contribution in pathology diagnosis and molecular biology

Conditions: Image-Guided Biopsy - Carcinoma, Bronchogenic / Diagnosis- Outpatients

Summary: in case of primary lung cancer, bone metastases biopsy can be done in initial diagnosis or follow-up. nevertheless, any study focus on rentability and biopsy complications of lytic bone lesion for the context of lung cancer. this study aims to demonstrate that ct scan guide percutaneous biopsy of lytic bone lesion help to anatomopathologic diagnosis and molecular biology with a low complication rate inasmuch a lung cancer is suspected. this study is observational, retrospective, one center

current progress in thoracic oncology require to be able to carry out analysis by molecular biology. so biopsies are done several times during cancer progression. but risk is high for a lung biopsy with enough sample, so a ct scan guide percutaneous biopsy of lytic bone metastases of lung cancer can be an alternative. in case of primary lung cancer, bone metastases biopsy can be done in initial diagnosis or follow-up. but this contribution in diagnostic (anatomopathologic an molecular biology) is poorly understood. it is demonstrated that to sample on lytic bone lesion have a failure rate lower than on calcified osseous lesion. nevertheless, any study focus on rentability and biopsy complications of lytic bone lesion for the context of lung cancer. this study aims to demonstrate that ct scan guide percutaneous biopsy of lytic bone lesion help to anatomopathologic diagnosis and molecular biology with a low complication rate inasmuch a lung cancer is suspected. this study is observational, retrospective, descriptive, one-center patient's records selection will be done by keyword search on the chu grenoble alpes radiology software. only records with bone biopsy register between january 2010 and june 2017 will be included.

Eligibility criteria:
inclusion criteria: * ct scan guide percutaneous biopsy of lytic bone metastases * register on chu grenoble alpes radiology software between january 2010 and june 2017 * patient who have a clinical context of lung cancer with bone metastases exclusion criteria: * person deprived of liberty by judicial order * opposition expressed by patient

Keywords: technology, radiologic - radiography, interventional - image-guided biopsy - early detection of cancer - carcinoma, bronchogenic / diagnosis - outpatients
comparison of the efficacy and safety of naldebain with conventional treatment after laparoscopic cholecystectomy

Conditions: Pain, Postoperative

Summary: to determine the effect and safety of naldebain versus morphine as needed in patients after laparoscopic cholecystectomy.

this is an open-labeled, randomized clinical trial. group a will receive one dose of naldebain before surgery. group b will receive morphine as needed. pain will be assessed for pacu, 4, 24, 48, 72 hours after surgery.

Eligibility criteria:
inclusion criteria: 1. male or female with 20 years old or older. 2. scheduled to electively undergo laparoscopic cholecystectomy. 3. ability and willingness to provide informed consent. exclusion criteria: 1. not willing to adhere to the study visit schedule and complete all study assessments. 2. history of hypersensitivity or allergy to opioid, or nsaids or sesame oil. 3. any clinically significant condition that may interfere with study assessments or compliance. 4. pregnant or breastfeeding. 5. medical history may cause abnormal intracranial pressure. 6. history of dependency, addiction, and withdrawal for narcotic drugs.